1. Field of the Invention
The present invention relates generally to a novel method of administering Modafinil, and to novel dosage forms containing Modafinil adapted for nasal administration.
2. Description of the Prior Art
Modafinil is a racemic compound of chemical formula 2-[(diphenylmethyl)sulfinyl] acetamide. Modafinil is a stimulant, the therapeutic activity of which has been well documented as a wakefulness-promoting agent. Modafinil has been utilized for the treatment of narcolepsy by promoting wakefulness in individuals with excessive daytime sleepiness associated with narcolepsy, and in the treatment of idiopathic hypersomnolence.
Modafinil and its enantiomers are white or whitish crystals that are practically insoluble in water and are only slightly soluble in lower alcohols. The racemic compound has a melting point of 163-165° C. The racemic compound and its enantiomers have the same characteristics stated above. Modafinil currently is administered in oral formulation as a tablet or multiple tablets, or parenterally. However, oral delivery of a therapeutically active amount of Modafinil suffers from a number of disadvantages:
(1) Modafinil administered in an oral formulation is absorbed from the intestinal track at an undesirably slow and uneven rate that leads to undesirable variations in blood levels and undesirably high dosage rates to achieve a therapeutic response leading to undesirable side effects;
(2) Modafinil administered in an oral formulation does not produce desirably high blood levels in a desirably short period of time;
(3) Modafinil administered in an oral formation may result in a significant amount not being absorbed because it is being wasted by metabolism or excretion;
(4) Modafinil administered in an oral formation may lead to further delay of absorption if taken in conjunction with food or other physiologically active agents that slow down the rate of absorption within the gastrointestinal system;
(5) Modafinil administered in an oral formation is administered as a tablet or multiple tablets which may lack the desirable ease of administration because some people may dislike the swallowing of tablets, or may have difficulty swallowing tablets, or are unable to swallow tablets, or may require a liquid to assist swallowing of tablets; and
(6) Modafinil-containing tablets also contain several inactive ingredients, including lactose, corn starch, magnesium silicate, croscarmellose sodium, povidone, magnesium stearate, and talc which may be considered undesirable because some people may dislike or be allergic to one or more of these inactive ingredients that comprise the Modafinil tablets.
Thus, there appears a need for improved delivery of Modafinil, which will provide enhanced bioavailability, minimized variations in blood levels, and achieve more rapid onset of activity, as compared to oral dosage forms, while at the same time providing relative ease of administration and reduced side effects compared to current oral delivery methods for administering Modafinil.